Panblok H7 Vaccine Adjuvanted With AS03 or MF59

NCT03283319 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: BP-I-17-002HHSO100201400004ITO# HHSO10033001T
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 4

Brief Summary

The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated by 28 days. Three different antigen dose levels of Panblok H7 will be tested.

Conditions

Influenza, Human

Keywords

Influenza; human; Influenza in Birds; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; MF59; AS03; Adjuvants; Immunologic

Outcome Measures

Primary Outcomes (8)

• Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03

  Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain

  Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)

• Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03

  Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.

  Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)

• Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59

  Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain

  Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)

• Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59

  Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.

  Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)

• Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03

  The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.

  Day 50

• Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59

  The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.

  Day 50

• Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03

  The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.

  Day 50

• Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59

  The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.

  Day 50

Secondary Outcomes (36)

• Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03

  Day 1 through Day 394

• Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59

  Day 1 through Day 394

• Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03

  Day 1 through Day 394

• Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59

  Day 1 through Day 394

• Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03

  Day 1 through Day 394

Study Arms (6)

3.75 ug Panblok H7 plus AS03

EXPERIMENTAL

Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 plus AS03

Biological: 3.75 ug Panblok H7; Biological: AS03

7.5 ug Panblok H7 plus AS03

EXPERIMENTAL

Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with AS03

Biological: 7.5 ug Panblok H7; Biological: AS03

15 ug Panblok H7 plus AS03

EXPERIMENTAL

Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with AS03

Biological: 15 ug Panblok H7; Biological: AS03

3.75 ug Panblok H7 plus MF59

EXPERIMENTAL

Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 adjuvanted with MF59

Biological: 3.75 ug Panblok H7; Biological: MF59

7.5 ug Panblok H7 plus MF59

EXPERIMENTAL

Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with MF59

Biological: 7.5 ug Panblok H7; Biological: MF59

15 ug Panblok H7 plus MF59

EXPERIMENTAL

Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with MF59

Biological: 15 ug Panblok H7; Biological: MF59

Interventions

3.75 ug Panblok H7 BIOLOGICAL

0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.

3.75 ug Panblok H7 plus AS03; 3.75 ug Panblok H7 plus MF59

7.5 ug Panblok H7 BIOLOGICAL

Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.

7.5 ug Panblok H7 plus AS03; 7.5 ug Panblok H7 plus MF59

15 ug Panblok H7 BIOLOGICAL

Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.

15 ug Panblok H7 plus AS03; 15 ug Panblok H7 plus MF59

MF59 BIOLOGICAL

0.5 mL MF59 (39 mg squalene/mL ) adjuvant.

15 ug Panblok H7 plus MF59; 3.75 ug Panblok H7 plus MF59; 7.5 ug Panblok H7 plus MF59

AS03 BIOLOGICAL

0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.

15 ug Panblok H7 plus AS03; 3.75 ug Panblok H7 plus AS03; 7.5 ug Panblok H7 plus AS03

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or nonpregnant female 18 to 49 years of age, inclusive, at the time of the first study vaccination.
• Provide written informed consent prior to the initiation of any study-related procedures.
• Are able to understand and comply with planned study procedures.
• Have a stable health status based on site investigator's clinical judgment, as established by physical examination, vital signs, and medical history.
• Have access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
• Agree to stay in contact with the study site for the duration of the study, have no current plans to move from the study area, and agree to provide updated contact information as necessary.

You may not qualify if:

• Have had a prior severe reaction to any influenza vaccine or have a known allergy to squalene-based adjuvants.
• Women who are pregnant or breast feeding. Women of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours prior to each vaccination.
• Women of childbearing potential are defined as postmenarcheal and premenopausal females capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal \>12 months, tubal ligation \>12 months, bilateral salpingo-oophorectomy, or hysterectomy.
• Women of childbearing potential who refuse to use an acceptable method of birth control from screening to Day 50 (Visit 7) or, if sexually active with a male partner, who have not used a reliable birth control method during the 2 months prior to screening.
• Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example: abstinence from penile-vaginal intercourse; oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female participant's Screening Visit, and this male is the sole partner for that participant (the information on the male partner's sterility can come from the site personnel's review of the participant medical records or interview with the participant on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
• Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months, or plans to receive immunosuppressive therapy/cytotoxic treatment during study participation.
• Have an active neoplastic disease or a history of any hematologic malignancy. However, participants with superficial skin cancer who do not require intervention other than local excision are not excluded.
• Have long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or prednisone equivalent (\>20 mg total dose per day) or high-dose inhaled steroids (\>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening in this study. However, participants on low-dose inhaled steroids (≤800 µg/day of beclomethasone dipropionate or equivalent) or topical steroids are not excluded.
• History of schizophrenia, bipolar disease, psychosis, or severe personality disorder.
• History of hospitalization for psychiatric illness, attempted suicide, or having been deemed a danger to self or others within the past 10 years.
• Have received immunoglobulin or other blood product (with the exception of Rho\[D\] immune globulin) within the 3 months prior to screening in this study.
• Have received any live vaccines within 4 weeks or inactivated or recombinant protein vaccines within 2 weeks prior to screening in this study or plan to receive such vaccines (including seasonal influenza vaccines) from screening through 21 days following the second dose of the study vaccine (Screening Visit through Day 50).
• Have an acute or chronic medical condition that, in the opinion of the site investigator, would render vaccination unsafe or would interfere with the evaluation of responses. This includes all PIMMCs such as Guillain Barré syndrome, narcolepsy, and current or history of autoimmune or chronic inflammatory disease.
• Have an acute illness, including body temperature greater than 100.4°F, at screening, immediately prior to each vaccination or, per participant report, within 3 days prior to each vaccination in this study.
• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to screening in this study or expect to receive an experimental agent during the study period.

Sponsors & Collaborators

• Biomedical Advanced Research and Development Authority: lead
• Rho, Inc.: collaborator

Study Sites (4)

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases

Interventions

MF59 oil emulsion

Condition Hierarchy (Ancestors)

Infections; Bird Diseases; Animal Diseases

Results Point of Contact

• Title: Silvija Tresnjak-Smith
• Organization: BARDA

Silvija.Tresnjak-Smith@hhs.gov

202-557-1993

Study Officials

• Mark Adams, MD

  Central Kentucky Research

  PRINCIPAL INVESTIGATOR

• Matthew Davis, MD

  Rochester Clinical Research

  PRINCIPAL INVESTIGATOR

• Carlos Fierro, MD

  Johnson County Clin-Trials

  PRINCIPAL INVESTIGATOR

• Terry Poling, MD

  Heartland Research Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of the six treatment groups at Day 1 and will receive the assigned dose of antigen and adjuvant on Day 1 and Day 29.

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: September 20, 2017
• Primary Completion: December 15, 2017
• Study Completion: November 9, 2018
• Last Updated: May 6, 2020
• Results First Posted: September 25, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)